About FDA

Improving Regulation and Regulatory Review

In accordance with Executive Order 13563, “Improving Regulation and Regulatory Review,” the Food and Drug Administration (FDA) is conducting a review of its existing regulations to determine, in part, whether they can be made more effective in light of current public health needs and to take advantage of and support advances in innovation.

The goal of this review of existing regulations, as with our other reviews, is to help ensure that FDA’s regulatory program is more effective and less burdensome in achieving its regulatory objectives.

FDA is requesting comment and supporting data on which, if any, of its existing rules are outmoded, ineffective, insufficient, or excessively burdensome and thus may be good candidates to be modified, streamlined, expanded, or repealed.

As part of this review, FDA also invites comment (PDF - 24 KB) to help us review our framework for periodically analyzing existing rules.

Background

FDA is responsible for protecting the public health by: (1) ensuring the safety and efficacy of human and veterinary drugs, biological products, medical devices, (2) ensuring the safety and security of our nation’s food supply, products that emit radiation, and, and (3) regulating the manufacture, marketing, and distribution of tobacco products. FDA also promotes the public health by striving to foster innovative approaches and solutions on for some of our nation’s most compelling health and medical challenges.

Currently, FDA has three main mechanisms that trigger a retrospective review of an existing regulation. First, a retrospective review may occur when there is a significant change in circumstances, such as advances in technology, new data or other information, or legislative change. Second, whenever FDA is revising an existing regulation, it reviews that regulation to determine if the underlying science and policy are still valid and whether the regulations should be updated based on current science, policy, data, or technology. The third mechanism is FDA’s Citizen Petition Process. Under 21 CFR 10.30, FDA provides a relatively simple mechanism for the public to request the Commissioner of Food and Drugs to issue, amend, or revoke a regulation by submitting a Citizen Petition.